Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Clinical Oncology Group
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Cisplatin; Mitomycin; Mitomycins; Vindesine

Criteria

Inclusion Criteria:

• Newly diagnosed, pathologically documented non-small cell lung cancer (NSCLC)

• Invasion to the first rib or more superior chest wall

• Age: 15-74 years old

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Ample organ function

• No prior chemo- or radiotherapy

• Signed informed consent

Exclusion Criteria:

• Metastasis to, or involvement of, mediastinal node (N2)

• Distant metastasis or dissemination to pleura/pericardium

• Active concomitant malignancy

• Unstable angina, recent myocardial infarction, heart failure

• Uncontrolled diabetes or hypertension

• Pregnant or lactating women

• Other severe complications